Michael Rieth

Pharmaceutical Microbiology (eBook, PDF)

Best Practices, Validation, Quality Assurance

• Format: PDF

Produktbeschreibung

All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation.

Written by the former head of biological quality assurance for one of Europe's biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including:

• General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenance
• Industrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methods
• Automation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testing
• Pharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal tests

Pharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.

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Produktdetails

• Verlag: Wiley-VCH
• Seitenzahl: 430
• Erscheinungstermin: 21. Februar 2025
• Englisch
• ISBN-13: 9783527848706
• Artikelnr.: 73462663

Autorenporträt

Michael Rieth received his biology doctorate from the Institute of Microbiology University of Gottingen. He entered into the pharmaceutical industry in 1988. From 1999 to 2014 he was Head of Biological Quality Assurance at Merck KGaA, Darmstadt. He then worked in the field of Global Regulatory Affairs until his retirement in 2020. He has written four books, including Pharmaceutical Microbiology in the German language, which was awarded the Wallhausser Prize in 2013.

Inhaltsangabe

1 Introduction to microbiology
2 General conditions for the operation of microbiological laboratories
3 Calibration and qualification of devices
4 Type culture maintenance
5 Industrial Hygiene
6 Ambient monitoring
7 Quality control
8 Process validation
9 Microbiological water examination
10 Rapid microbiological methods
11 Automation in the microbiology laboratory
12 Quality assurance
13 Identification of Microorganisms
14 Cleaning, sterilization, decontamination, disposal
15 Contract testing
Appendix
Networks and associations
Recommended reading
Glossary